If it is prescription they can charge medicare and or the VA, if it was just a gadget or licensable piece of technology the profit margins are likely lower.

PS - Not justifying, just explaining the business model.

Exactly. If you can pay $10 for a subscription, they can’t charge $500 to a healthcare provider.

Absolutely true, but it also means the ability to pay per-user liability insurance rates that a $10 subscription would not cover. Being a medical product is not all upside.

Simply because an Health Plan is willing to pay 10x - 100x more than a consumer is willing to pay.

Sounds like it would be reasonably easy for someone else to reimplement? Are those sensors available to third-party app developers?

Because it's FDA approved. And because it's FDA approved, they can market it as a medical device that treats a disease.

Being cleared by the FDA means that they have demonstrated evidence, which is linked in the original Apple page: https://pubmed.ncbi.nlm.nih.gov/36305584/

Like others have said, it's likely prescription only because being FDA approved as a treatment for a specific disease allows it to be paid by VA or other health insurances.

FDA approval processes and guidelines are notoriously rigid and increasingly antiquated, and likely ended up requiring "the whole system - i.e. watch + app + phone" to be approved together, making the package pretty pricey - and in awesome circular logic now basically require insurance to pick up the tab.

There are some efforts to make "digiceuticals" more streamlined to approve but... the FDA is unfortunately very necessary but painfully in need of reform.